Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain

Not Applicable

Terminated

• Conditions: Nutrition Disorders; Malnutrition
• Interventions: Dietary Supplement: Oral nutrition supplement; Other: Nutritional advice

• Registration Number: NCT03944161
• Lead Sponsor: Asociación Española de Fabricantes y Distribuidores de Productos de Nutrición Enteral

Brief Summary

The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.

Detailed Description

COSNUT pretends to assess the cost-effectiveness and cost-utility of oral nutritional supplementation (ONS) in persons with malnutrition and other clinical conditions. The effectiveness will be evaluated by comparing the intervention group having ONS vs a control group only with nutrition advice. The effectiveness and resource use will be collected using quality of life assessment tools, body mass index, change in malnutrition state, number of hospital admissions, medical visits...

Unitary costs for Spain will be extracted from databases and official publications and will be applied to the number of resources used in order to calculate the costs in each of the groups. Finally, the incremental cost-effectiveness ratio will be estimated and presented.

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Study Start: 2019-11-20
• Status Verified: 2022-05
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• >18 y
• Nutritional status B or C (GSA criteria)
• Presenting one of the following conditions:
• Cancer patient after surgery, radiotherapy on antineoplastic treatment.
• Hip fracture
• Heart failure NYHA (New York Heart Association) III-IV.
• Breathing failure GOLD 3 o 4: FEV1 (forced expiratory volume at one second ) <50%.
• Renal failure GFR<30 (glomerular filtration rate )
• Participants agreeing the informed consent

Exclusion Criteria

• Cancer patients: esophagus, stomach, pancreas and Head and neck
• Hospital admitted patients at the time of recruitment
• Life expectancy below 3 months
• Pregnant or nursing women
• Use of oral nutritional supplements in the three months prior the enrolment
• History of allergy to oral nutritional supplements
• Diabetes mellitus type 1.
• Participation in any other study at the time of enrolment
• Cognitive limitations to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Oral nutrition supplement	Participants in the intervention group will receive an oral nutrition supplement bottle (200/220 ml) with \>20 % of protein and 1.5 Kcal/ml without fibre twice a day during 12 weeks and nutritional advice.
Intervention group	Nutritional advice	Participants in the intervention group will receive an oral nutrition supplement bottle (200/220 ml) with \>20 % of protein and 1.5 Kcal/ml without fibre twice a day during 12 weeks and nutritional advice.
Control group	Nutritional advice	Participants in the control group will receive nutrition advice

Primary Outcome Measures

Name	Time	Method
Body mass index	6 months	Index for relating weight to height. Abbreviated BMI. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared
Strength	from baseline-6 months	hand grip strength test
Strength and endurance	from baseline-6 months	30-second Chair Stand Test
Change in nutritional status	from basal-6 months	Change in the Global Subjective Assessment (this scale categorize participants into A, B or C being A the best nutritional status and C the worst.)
Functional status	from baseline-6 months	Katz index (this index categorize in one of 7 categories: A,B,C,D,E,F,G from independent for all functions (A) to dependent for all functions (G))
Number of Hospital admittance	at 30 days	Number of admittance from randomization
Number of Hospital admittances	from randomization to 6 months	Number of admittance from randomization
Number of participants Diagnosed of malnutrition	from baseline-6 months	Diagnosis of malnutrition using GLIM criteria
Health related quality of life	from baseline-6 months	EuroQoL 5 dimensions and 5 levels(EQ5D5L) (scale between 0 which is the death and 1 which is the best health status)
Number of Medical doctor visits	from randomization to 6 months	Visits to any outpatient medical office

Secondary Outcome Measures

Name	Time	Method
Number of deaths	from randomization to 6 months	mortality registry
Number of secondary effects related to the intervention	from randomization to 6 months	Any undesirable effect due to the intervention
Number of Infections	at 6 months	Any diagnosed infection by a medical doctor

Trial Locations

Locations (7)

Complejo Hospitalario Regional Reina Sofía; 🇪🇸 Córdoba, Andalucía, Spain

Complejo Asistencial de Segovia; 🇪🇸 Segovia, Castilla Y León, Spain

Hospital Universitari Germans Trias I Pujol de Badalona; 🇪🇸 Badalona, Cataluña, Spain

Hospital Universitari Joan Xxiii de Tarragona; 🇪🇸 Tarragona, Cataluña, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Aragón, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Castilla Y León, Spain

Hospital General Nuestra Señora Del Prado; 🇪🇸 Talavera De La Reina, Toledo, Spain